Regulatory Affairs Specialist (Pharmaceuticals)

Job description / Role

We are looking for a Pharmaceutical Regulatory Affairs Specialist who is responsible for all Product Classification and Product Registration and to ensure that all documents required are available and are submitted on time.

Location: Dubai

Responsibilities

- Registration of pharmaceutical and medical devices etc at DHA
- Studying scientific and legal documents
- Gathering, evaluating, organising, managing and collating information in a variety of formats
- Ensuring compliance with regulations set by DHA
- Maintaining familiarity with company product ranges
- Planning, undertaking and overseeing product trials and regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
- Analysing complicated information, including trial data
- Offering advice about company policies, practices and systems
- Obtaining marketing permission
- Outlining requirements for labelling, storage and packaging
- Using a variety of specialist computer applications
- Liaising and negotiating with regulatory authorities
- Providing advice about regulations to manufacturers/scientists
- Writing comprehensible, user-friendly, clear product information leaflets and labels
- Ensuring that quality standards are met and submissions meet strict deadlines
- Preparing documentation.

Requirements

Requirements

- Bachelor’s in science (Pharmacy will be an added advantage)
- Minimum of 4 years of experience in a similar role
- Excellent verbal and written communication skills
- Strong interpersonal skills and excellent customer service skills
- Highly developed attention to detail
- Strong project management skills
- Ability to work well in a team environment

About the Company

Najma Human Resources and Training Consultancy, is committed to professional service in Human Resource and Training.

Najma, has been operating successfully since 1997 and has been offering consultancy service to a number of reputed organizations in the Middle East, Eastern Europe and Africa.